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Quality Management System
Diagnostic Radiology
Introduction
A quality management system (QMS) is essential to a safe and efficiently run diagnostic radiology department, providing quality clinical images while maintaining patient and staff radiation doses as low as reasonably achievable. Quality management includes all aspects of medical imaging technology such as room and workflow design, equipment selection, equipment purchase, installation oversight, acceptance testing, commissioning, quality control, on-going equipment maintenance and support, and disposal at the end of the equipment’s life. Quality management must also provide oversight of imaging informatics systems in the imaging department as this has become an integral part of the today’s imaging department.
A QMS objective is continuous quality improvement, focusing on the following elements:
- The organization’s objectives and policies, documented procedures consistent with these objectives and policies,
- Written practice instructions for staff; and
- Monitoring, recording and auditing of practice.
It is important to note that the QMS is not a collection of procedures, tasks and documents. The QMS must be designed specifically for each individual radiology facility. All the components need to fit together, and the inputs and outputs need to be defined and connected. Therefore, the QMS is a set of interrelated and interacting processes that achieves the quality policy and quality objectives of the radiology facility and form an integral part of the hospital’s management system.
Quality assurance (QA) programme is part of a QMS and is focused on providing confidence that the quality needs or expectations are fulfilled. The QA includes all planned and systematic actions necessary to provide adequate confidence that an item, process or service will satisfy given requirements regarding quality. As such, it is wide ranging, covering all relevant procedures, activities and actions, and hence, all groups of staff involved in the diagnostic radiology process. The concept of QA within the radiological facility covers, in its widest sense, all those factors that affect the intended outcome, that is, a clinical diagnosis.
Quality control (QC) is the process through which the actual quality performance is measured and compared with existing standards. QC also includes the actions necessary to maintain or re-establish conformance with standards. QC is one part of overall QA programme.
The medical physicist must understand all the essential elements of a QMS and be able to design the structure of such systems. The key to quality management is a good understanding of the concepts of quality assurance, quality control, and continuous quality improvement.
Quality assurance programme for equipment
Much of the complexity of modern radiological imaging comes from the equipment and associated technical processes. A quality assurance (QA) programme for equipment demands a strong commitment from the facility and institutional leadership to provide the necessary resources of time, personnel and budget.
There are five stages applicable to QA for imaging equipment: equipment specification and tendering process, critical examination, acceptance, commissioning and routine performance testing. Notably, the QA programme should cover the entire process from the initial decision to adopt a particular procedure through to the interpretation and recording of results. QA also includes a systematic control methodology involving the following components:
- Measurements of the physical parameters of medical radiological equipment prior to clinical use on patients (i.e., at the time of acceptance and commissioning) and periodically thereafter and after any major maintenance that could affect patient safety;
- Implementation of corrective actions if measured values of the physical parameters are outside tolerances;
- Verification of the appropriate physical and clinical factors used in patient diagnosis;
- Documentation of relevant procedures and results. This should include a manual that defines clear lines of responsibility, outlines the individual quality control tests performed, gives the test frequencies, is useful for staff training, facilitates audit of a service and helps to keep information within the service;
- Verification of the appropriate calibration and conditions of the operation of dosimetry and monitoring equipment;
- Optimization of clinical protocols and equipment operation to achieve the aims of QA;
- Regular and independent audits of the QA programme for medical exposures.
Medical physicist are responsible for developing and implementing the physical and technical aspects of the QA programmes in diagnostic radiology.
Life cycle of imaging equipment
Effective maintenance is necessary to ensure efficient operation and minimum disruptions in service, as all equipment in a radiographic department has a limited lifespan. The equipment life cycle is sometimes referred to as an equipment quality assurance cycle. The cycle begins with the decision to purchase equipment and is completed with the disposal of the equipment. Maintenance is a vital part of the cycle. Typical life cycle components for an imaging system are: need analysis, equipment specification, tender process and purchase contract, installation, and acceptance and commissioning. Furthermore, the life cycle includes matters related to clinical use, maintenance and support, and routine performance testing, as a part of a more general quality assurance programme.
Management of medical imaging equipment during its life cycle is a major responsibility of the diagnostic radiology medical physicist. The medical physicist is responsible for the technical aspects of medical imaging equipment, who provides advice in equipment selection, specification, and purchase. Since a major operational cost is equipment service and repair parts, the medical physicist must manage these aspects of the equipment life cycle.
Critical examination, acceptance and commissioning
Critical examinations, acceptance and commissioning of imaging equipment are also part of the equipment life cycle.
At the critical examination, the operation of safety features and warning tools incorporated into the equipment are inspected to ensure that there is sufficient protection of the staff, visitors and patients against exposure to ionizing radiation. Acceptance assures that the facility is getting the equipment and performance specified in the purchase agreement, a vitally important step when purchasing costly equipment. Once the integrity and performance of the equipment has been assured, commissioning provides information necessary for clinical use and establishes base line measurements for future quality control tests.
After installation is complete, the medical physicist, in conjunction with other personnel (e.g. a representative of the equipment supplier and regulatory inspector), should undertake a critical examination of the installation. A critical examination is appropriate when there could be potential radiation protection implications associated with an incorrect installation, such as failure of the safety features or inadequate shielding. An experienced medical physicist can selectively examine the features that are most likely to affect safety (critical) instead of performing a long list of prescriptive tests, and based on the results obtained, proceed with more detailed tests.
Acceptance testing involves the verification of equipment specifications and features by representatives of the installer and the facility medical physicist. Acceptance may be a matter of simply completing a checklist. Any significant discrepancy should be notified formally to the contractor, who should be required to undertake corrective action. During acceptance testing, a qualified person should check the electrical and mechanical safety of any new installation. Acceptance testing occurs immediately after the equipment is installed (before commissioning) and approximately one month before the end of the warranty period. The later assures that the equipment meets the specifications at the time of purchase before the warranty expires, and provides sufficient time to notify the vendor or manufacturer and have the issues resolved at no cost. During acceptance, it is essential that the medical physicist work with the service engineers installing equipment so problems can be resolved as they are discovered. This will lead to a faster installation and assure that the equipment is performing to specification when the installation is complete.
After acceptance, commissioning is carried out by the facility representative, usually a medical physicist, to ensure that the equipment is ready for clinical use and to establish baseline values for future comparisons with the results of subsequent routine performance tests. Testing should include all parameters and conditions of use that are to be expected in clinical use. During commissioning the medical physicist provides information necessary for clinical use of the equipment, e.g., establishes scan protocols for a CT scanner. If vendor provided protocols are to be used, the medical physicist must assure that the image quality and patient dose are optimized with these protocols. After major interventions on the equipment, the relevant commissioning tests may need to be repeated to establish new baseline values, for example, after an X ray tube or image receptor are replaced or new software is installed.
The same medical physicist may undertake the critical examination, acceptance and commissioning. Although the tests may be combined, the purpose of each should remain distinct.
Routine performance testing
Routine performance (or constancy) testing, also known as quality control (QC) testing, consist of tests that are undertaken either regularly or after maintenance or repairs to detect any changes equipment performance that would require corrective action. In other words, QC tests are intended to verify the stability of the operation of the equipment or elements used to acquire the medical images.
Routine performance tests are a subset of the commissioning tests and will generally involve staff with different levels of expertise. Frequent tests that are quick to perform are usually undertaken locally (e.g., by a radiographer), with advice from a medical physicist, whereas more complex and time-consuming tests may require specialized expertise and instrumentation. A collaborative, multidisciplinary approach to routine performance testing is essential.
The QC tests can be described in various ways. The most important characteristics can be described as follows:
- Frequency of test, e.g., varying from daily to yearly, depending on equipment characteristics and the clinical workload;
- Priority, e.g., essential or desirable;
- Performance standards, e.g., acceptable or achievable;
- Test types, e.g., repeatability or consistency.
Management of the routine QC of medical imaging equipment is a major responsibility of the medical physicist and includes developing the QC protocols, implementing the program, overseeing the program, and determining corrective action is needed.
The Handbook of Basic Quality Control Tests for Diagnostic Radiology is a quick reference guide on how to perform each test and draws attention to the common issues and mistakes that could undermine the results or the evaluation of a given test. It is divided into sections dedicated to a specific imaging modality, such as radiography, fluoroscopy, CT and mammography and accompanied by excels for easy data collection and videos.
Remote and automated quality control
Regular quality control testing of medical radiological equipment has been shown to improve clinical image quality and reduce patient radiation exposure. Unfortunately it has been largely overlooked throughout the world. As part of the quality assurance programme, various tests need to be performed at certain time intervals such as annually, by-annually, monthly, or weekly tests. Annual testing alone is inadequate to detect short term fluctuations in some critical components of the imaging chain. Remote quality control tools are used to facilitate daily or weekly testing to ensure consistency between comprehensive annual evaluations. Additionally, automated quality control tools allow for more advanced analysis of image quality parameters. However, most existing efforts involves complicated and expensive test objects and infrastructures. The IAEA developed a remote and automated solution for radiography and mammography quality control using simple, inexpensive test objects (phantoms) and a free software program. The phantoms enable quality control tests to be performed on a daily or weekly basis using a state-of-the-art detectability index (d′), and the accompanying software allows for complete and automated evaluation of the principal performance characteristics of the imaging chain. The IAEA methodology can be considered part of a comprehensive solution that can facilitate basic supervision of radiological X ray equipment performance to be conducted remotely, under the guidance of a clinically qualified medical physicist. The IAEA publication is accompanied by supplementary material to support the remote/automated quality control process: • Two excel files (one for radiography and one for mammography) for proper documentation of the results; • Real size blueprints of proposed phantoms (radiography, mammography), allowing users to accurately manufacture them; • Dedicated software to automatically analyse images generated by the phantoms and provide advanced and sophisticated measures of image quality. • Training material to facilitate implementation of the remote and automated QC IAEA methodology • Frequent questions and answers
Clinical audit
A key element in managing quality in health care is clinical audit. Clinical audit is a systematic review of the medical procedures against agreed standards for good procedures, with the aim of improving the quality and outcome of patient care.
Clinical audit involves evaluation of data, documents, and resources to check performance against standards, with a purpose:
- To improve the quality of patient care;
- To promote the effective use of resources;
- To enhance the provision and organization of clinical services;
- To further professional education and training.
With these objectives, clinical audit should be considered as an integral part of quality management and clinical governance, making it part of the overall quality improvement process. It aims to continuously improve medical practices and should be conducted regularly, ensuring that the audit cycle is completed. It is a truly multidisciplinary, multiprofessional activity, and must be carried out by auditors with extensive knowledge and experience of the radiological practices to be audited, i.e., they must generally be professionals involved in clinical work within these practices.
Clinical audit should comprise both internal and external assessments and these should supplement each other. Internal audits are undertaken within a given healthcare setting by staff from the same institution, whereas the audit findings can be externally reviewed. In small health care units, internal audits would, rather, be self-assessments. External audits involve the use of auditors who are independent of the radiology department.
Therefore, clinical audit should be able to identify the strengths of a radiology department, as well as areas requiring improvement. Ultimately, the main beneficiary of this process is the patient.
The IAEA has developed and published a methodology for comprehensive hospital audits in diagnostic radiology (QUAADRIL). The QUAADRIL audit team includes a minimum: a radiologist, a diagnostic radiology medical physicist and a radiographer. It examines the processes in diagnostic radiology, with particular attention given to radiation-related activities as described in the International Basic Safety Standards and their related dosimetry protocols and QA guidelines. Feedback from the hospitals showed that the audit process experience was well-received and beneficial towards improving practice in radiology departments.
For those interested in understanding more about the added value of a Quality Management System in their department or wish to establish such as system below there is additional training material:
- Basics of Quality - What is quality and why is it important?
- Roles and responsibilities for Quality and safety: who are the stakeholders and how to involve them.
- Key Performance Indicators and their role in measuring quality
- Drafting a Quality Manual-the medical physics perspective
- How to develop a roadmap for a successful QMS
- Drafting policies and procedures- the medical physics perspective
- Equipment management as part of a QMS
- What is a clinical audit and how can the medical physicist contribute?